Coronary Artery Disease
Conditions
Brief summary
Conventionally, a relatively high level of fraction of inspired oxygen (FiO2) has been used for secure a margin of safety in patients undergoing cardiac surgery including off-pump coronary artery bypass grafting (OPCAB). Since the potential adverse effects of hyperoxemia (via reactive oxygen species, vasocontriction, perfusion heterogeneity, myocardiac injury, etc.), various studies on this topic has been performed. However, the results are conflicting and inconsistent, and the consensus about whether the use of additional oxygen supply in cardiac surgery has not been reached among practitioners yet. This study is a multicenter study (Seoul National University, Asan Medical Center, Severance Hospital) where the effect of different level of FiO2 on postoperative clinical outcomes is evaluated.
Detailed description
A sub-study will also be conducted in part of patients of the present study. In 40 out of 500 (expected) patients, two different levels of FiO2 will be sequentially set with a 5-minute interval after the induction of general anesthesia. Mixed venous and regional cerebral oxygen saturation will then be recorded according to the change of FiO2.
Interventions
A fraction of inspired oxygen level during off-pump coronary artery bypass grafting will be set differently between the study groups: 0.3 vs 0.8.
Sponsors
Asan Medical Center
Severance Hospital
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients scheduled for elective off-pump coronary artery bypass grafting
Exclusion criteria
* emergency * robot-assisted surgery * minimally invasive cardiac surgery requiring thoracotomy/one-lung anesthesia * preoperative pulmonary morbidity requiring oxygen therapy * preoperative use of ECMO or IABP * preoperative tracheal intubation or mechanical ventilation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hospital LOS | From the beginning of surgery until the hospital discharge after surgery through study completion, an expected average of two weeks | length of hospital stay after off-pump coronary artery bypass grafting |
Countries
South Korea
Outcome results
None listed